Page 1/7

Material Safety Data Sheet

acc. to ISO/DIS 11014
Printing date 06/23/2011 Reviewed on 06/23/2011

1 Identification of the substance/mixture and of the company/undertaking

· Product identifier
· Trade name: AIA-PACK CALIBRATOR SET SERIES 1 : Please refer to ANNEX I
AIA-PACK SAMPLE DILUTING SOLUTION Series : Please refer to ANNEX II
AIA-PACK TPOAb CONTROL SET : 020490
AIA-PACK TPOAb CONJUGATE : 020708
AIA-PACK TgAb CONJUGATE : 020709
AIA-PACK RBC FOLATE HEMOLYZING REAGENT 2: 020711
ST AIA-PACK Cystatin C CONTROL SET : 025417
· Relevant identified uses of the substance or mixture and uses advised against
· Application of the substance / the preparation In Vitro Diagnostics.
· Details of the supplier of the safety data sheet
· Manufacturer / Supplier:
TOSOH CORPORATION TOSOH BIOSCIENCE, INC.
3-8-2 Shiba, Minato-ku 6000 Shoreline Ct.; Suite 101
Tokyo 105 -8623 South San Francisco, CA94080
JAPAN USA

Tel. : + 81 3 5427 5181 Phone : + 1 614 317 1909 or (800) 248 6764
Fax : + 81 3 5427 5220 Fax : + 1 877 898 9883 or (800) 685 7595
· Information department:
QA-RA: susan.koss@tosoh.com www.diagnostics.us.tosohbioscience.com
· Emergency telephone number: Poison Control Center: + 1 800 222 1222

2 Composition/information on ingredients
· Chemical characterization: Substances
· CAS No. Description
7732-18-5 water, distilled, conductivity or of similar purity
· Identification number(s)
· EINECS Number: 231-791-2
· Chemical characterization: Mixtures
· Description: Mixture of the substances listed below with nonhazardous additions.
· Dangerous components: Void

3 Hazards identification
· Classification of the substance or mixture
The product is not classified according to the Globally Harmonized System (GHS).
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC Not applicable.
· Information concerning particular hazards for human and environment:
The product does not have to be labelled due to the calculation procedure of international guidelines.
· Classification system:
The classification was made according to the latest editions of international substances lists, and expanded
upon from company and literature data.
· Label elements
· Labelling according to EU guidelines:
Observe the general safety regulations when handling chemicals.
The product is not subject to identification regulations according to directives on hazardous materials.
· Classification system:
· NFPA ratings (scale 0 - 4)
Health = 0
0 Fire = 0
0 0 Reactivity = 0
(Contd. on page 2)
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 Page 2/7
Material Safety Data Sheet
acc. to ISO/DIS 11014
Printing date 06/23/2011 Reviewed on 06/23/2011

Trade name: AIA-PACK CALIBRATOR SET SERIES 1 : Please refer to ANNEX I

AIA-PACK SAMPLE DILUTING SOLUTION Series : Please refer to ANNEX II
AIA-PACK TPOAb CONTROL SET : 020490
AIA-PACK TPOAb CONJUGATE : 020708
AIA-PACK TgAb CONJUGATE : 020709
AIA-PACK RBC FOLATE HEMOLYZING REAGENT 2: 020711
ST AIA-PACK Cystatin C CONTROL SET : 025417

(Contd. of page 1)
· HMIS-ratings (scale 0 - 4)
HEALTH 0 Health = 0
FIRE 0 Fire = 0
REACTIVITY 0 Reactivity = 0
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

4 First aid measures

· Description of first aid measures
· General information: No special measures required.
· After inhalation: Supply fresh air; consult doctor in case of complaints.
· After skin contact: Generally the product does not irritate the skin.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: If symptoms persist consult doctor.
· Information for doctor:
· Most important symptoms and effects, both acute and delayed No further relevant information available.
· Indication of any immediate medical attention and special treatment needed
No further relevant information available.

5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water spray. Fight larger fires with water spray or alcohol resistant foam.
· Special hazards arising from the substance or mixture No further relevant information available.
· Advice for firefighters
· Protective equipment: No special measures required.

6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures Not required.
· Environmental precautions: Dilute with plenty of water.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
· Reference to other sections
No dangerous substances are released.
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for disposal information.

7 Handling and storage

· Handling:
· Precautions for safe handling Store in cool, dry place in tightly closed receptacles.
(Contd. on page 3)
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 Page 3/7
Material Safety Data Sheet
acc. to ISO/DIS 11014
Printing date 06/23/2011 Reviewed on 06/23/2011

Trade name: AIA-PACK CALIBRATOR SET SERIES 1 : Please refer to ANNEX I

AIA-PACK SAMPLE DILUTING SOLUTION Series : Please refer to ANNEX II
AIA-PACK TPOAb CONTROL SET : 020490
AIA-PACK TPOAb CONJUGATE : 020708
AIA-PACK TgAb CONJUGATE : 020709
AIA-PACK RBC FOLATE HEMOLYZING REAGENT 2: 020711
ST AIA-PACK Cystatin C CONTROL SET : 025417

(Contd. of page 2)
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and receptacles: No special requirements.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: None.
· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection

· Additional information about design of technical systems: No further data; see item 7.
· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the creation were used as basis.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
The usual precautionary measures for handling chemicals should be followed.
· Breathing equipment: Not required.
· Protection of hands:
The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.
Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/
the chemical mixture.
Selection of the glove material on consideration of the penetration times, rates of diffusion and the
degradation
· Material of gloves
The selection of the suitable gloves does not only depend on the material, but also on further marks of quality
and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the
resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the
application.
· Penetration time of glove material
The exact break through time has to be found out by the manufacturer of the protective gloves and has to be
observed.
· Eye protection: Goggles recommended during refilling.

9 Physical and chemical properties

· Information on basic physical and chemical properties
· General Information
· Appearance:
Form: Solution
Color: Colorless
· Odor: Odorless
· Odour threshold: Not determined.
· pH-value: Not determined.
(Contd. on page 4)
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 Page 4/7
Material Safety Data Sheet
acc. to ISO/DIS 11014
Printing date 06/23/2011 Reviewed on 06/23/2011

Trade name: AIA-PACK CALIBRATOR SET SERIES 1 : Please refer to ANNEX I

AIA-PACK SAMPLE DILUTING SOLUTION Series : Please refer to ANNEX II
AIA-PACK TPOAb CONTROL SET : 020490
AIA-PACK TPOAb CONJUGATE : 020708
AIA-PACK TgAb CONJUGATE : 020709
AIA-PACK RBC FOLATE HEMOLYZING REAGENT 2: 020711
ST AIA-PACK Cystatin C CONTROL SET : 025417

(Contd. of page 3)

· Change in condition
Melting point/Melting range: Undetermined.
Boiling point/Boiling range: Undetermined.
· Flash point: Not applicable.
· Ignition temperature:
Decomposition temperature: Not determined.
· Auto igniting: Product is not selfigniting.
· Danger of explosion: Product does not present an explosion hazard.
· Explosion limits:
Lower: Not determined.
Upper: Not determined.
· Vapor pressure at 20°C (68°F): 23 hPa (17 mm Hg)
· Density: Not determined.
· Relative density Not determined.
· Vapour density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible.
· Segregation coefficient (n-octonol/water): Not determined.
· Viscosity:
Dynamic: Not determined.
Kinematic: Not determined.
· Solvent content:
Organic solvents: 0.0 %
· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
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(Contd. on page 5)

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 Page 5/7
Material Safety Data Sheet
acc. to ISO/DIS 11014
Printing date 06/23/2011 Reviewed on 06/23/2011

Trade name: AIA-PACK CALIBRATOR SET SERIES 1 : Please refer to ANNEX I

AIA-PACK SAMPLE DILUTING SOLUTION Series : Please refer to ANNEX II
AIA-PACK TPOAb CONTROL SET : 020490
AIA-PACK TPOAb CONJUGATE : 020708
AIA-PACK TgAb CONJUGATE : 020709
AIA-PACK RBC FOLATE HEMOLYZING REAGENT 2: 020711
ST AIA-PACK Cystatin C CONTROL SET : 025417

(Contd. of page 4)

11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
26628-22-8 sodium azide
Oral LD50 27 mg/kg (rat)
Dermal LD50 20 mg/kg (rabbit)
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritating effect.
· Sensitization: No sensitizing effects known.
· Additional toxicological information:
The product is not subject to classification according to internally approved calculation methods for
preparations:
When used and handled according to specifications, the product does not have any harmful effects according
to our experience and the information provided to us.

12 Ecological information
· Toxicity
· Acquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Behavior in environmental systems:
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Generally not hazardous for water
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

13 Disposal considerations
· Waste treatment methods
· Recommendation: Smaller quantities can be disposed of with household waste.
· Uncleaned packagings:
· Recommendation: Disposal must be made according to official regulations.
· Recommended cleansing agent: Water, if necessary with cleansing agents.

14 Transport information
· DOT regulations:
· Hazard class: -
(Contd. on page 6)
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 Page 6/7
Material Safety Data Sheet
acc. to ISO/DIS 11014
Printing date 06/23/2011 Reviewed on 06/23/2011

Trade name: AIA-PACK CALIBRATOR SET SERIES 1 : Please refer to ANNEX I

AIA-PACK SAMPLE DILUTING SOLUTION Series : Please refer to ANNEX II
AIA-PACK TPOAb CONTROL SET : 020490
AIA-PACK TPOAb CONJUGATE : 020708
AIA-PACK TgAb CONJUGATE : 020709
AIA-PACK RBC FOLATE HEMOLYZING REAGENT 2: 020711
ST AIA-PACK Cystatin C CONTROL SET : 025417

(Contd. of page 5)

· Land transport ADR/RID (cross-border):

· ADR/RID class: -
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Sara
· Section 355 (extremely hazardous substances):
All ingredients are listed.
· Section 313 (Specific toxic chemical listings):
All ingredients are listed.
· TSCA (Toxic Substances Control Act):
All ingredients are listed.
· Proposition 65
· Chemicals known to cause cancer:
None of the ingredients is listed.
· Chemicals known to cause reproductive toxicity for females:
None of the ingredients is listed.
· Chemicals known to cause reproductive toxicity for males:
None of the ingredients is listed.
· Chemicals known to cause developmental toxicity:
None of the ingredients is listed.
· Carcinogenic categories
· EPA (Environmental Protection Agency)
None of the ingredients is listed.
· IARC (International Agency for Research on Cancer)
None of the ingredients is listed.
· NTP (National Toxicology Program)
None of the ingredients is listed.
· TLV (Threshold Limit Value established by ACGIH)
26628-22-8 sodium azide A4
· NIOSH-Ca (National Institute for Occupational Safety and Health)
None of the ingredients is listed.
(Contd. on page 7)
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 Page 7/7
Material Safety Data Sheet
acc. to ISO/DIS 11014
Printing date 06/23/2011 Reviewed on 06/23/2011

Trade name: AIA-PACK CALIBRATOR SET SERIES 1 : Please refer to ANNEX I

AIA-PACK SAMPLE DILUTING SOLUTION Series : Please refer to ANNEX II
AIA-PACK TPOAb CONTROL SET : 020490
AIA-PACK TPOAb CONJUGATE : 020708
AIA-PACK TgAb CONJUGATE : 020709
AIA-PACK RBC FOLATE HEMOLYZING REAGENT 2: 020711
ST AIA-PACK Cystatin C CONTROL SET : 025417

(Contd. of page 6)
· OSHA-Ca (Occupational Safety & Health Administration)
None of the ingredients is listed.
· Product related hazard informations:
Observe the general safety regulations when handling chemicals.
The product is not subject to identification regulations according to directives on hazardous materials.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
This information is based on our present knowledge. However, this shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International
Carriage of Dangerous Goods by Road)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the
International Transport of Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
DOT: US Department of Transportation
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
ACGIH: American Conference of Governmental Industrial Hygienists
EINECS: European Inventory of Existing Commercial Chemical Substances
CAS: Chemical Abstracts Service (division of the American Chemical Society)
NFPA: National Fire Protection Association (USA)
HMIS: Hazardous Materials Identification System (USA)
LC50: Lethal concentration, 50 percent
LD50: Lethal dose, 50 percent
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ANNEX I: AIA-PACK CALIBRATOR SET Series 1:
Revision: 3/05/2011

Catalogue
Description
Number

020302 AIA-PACK 27.29 CALIBRATOR SET

020352 AIA-PACK AFP CALIBRATOR SET
020353 AIA-PACK FER CALIBRATOR SET
020354 AIA-PACK CEA CALIBRATOR SET
020358 AIA-PACK T4 CALIBRATOR SET
020361 AIA-PACK βHCG CALIBRATOR SET
020363 AIA-PACK PA CALIBRATOR SET
020365 AIA-PACK FSH CALIBRATOR SET
020381 AIA-PACK PROG CALIBRATOR SET
020382 AIA-PACK TT3 CALIBRATOR SET
020390 AIA-PACK TPOAb CALIBRATOR SET
020394 AIA-PACK TSH 2rd-Gen CALIBRATOR SET
020395 AIA-PACK IgEII CALIBRATOR SET
025304 ST AIA-PACK Testosterone CALIBRATOR SET
025312 ST AIA-PACK PSA II CALIBRATOR SET
025317 ST AIA-PACK Cystatin C CALIBRATOR SET
025322 ST AIA-PACK DHEA-S CALIBRATOR SET

025374
0025374 AIA PACK E2 CALIBRATOR SET
ST AIA-PACK

Description ( on outer packaging) Description concerned item( as on label)

ST AIA-PACK cTnI 2nd-Gen CALIBRATOR SET (025305)
ST AIA-PACK Intact PTH CALIBRATOR SET(025313)
AIA-PACK RBC FOLATE CALIBRATOR SET (020314)
ST AIA-PACK ACTH CALIBRATOR SET (025321)
AIA-PACK PRL CALIBRATOR SET (020355)
AIA-PACK BMG CALIBRATOR SET (020359)
AIA-PACK IRI CALIBRATOR SET (020360)
AIA-PACK PAP CALIBRATOR SET (020362)
AIA-PACK HGH CALIBRATOR SET(020366)
AIA-PACK CK-MB CALIBRATOR SET (020369)
AIA-PACK C-Peptide CALIBRATOR SET(020384)
AIA-PACK 19-9 CALIBRATOR SET (020371)
AIA-PACK CA 125 CALIBRATOR SET (020388)
AIA-PACK TgAb CALIBRATOR SET (020391)
AIA-PACK FOLATE CALIBRATOR SET (020392)
ST AIA-PACK LH II CALIBRATOR SET (025396)
ST AIA-PACK Myoglobin CALIBRATOR SET (025397)
ST AIA-PACK cTnI 2nd-Gen CALIBRATOR (1)
ST AIA-PACK Intact PTH CALIBRATOR (1)
AIA-PACK RBC FOLATE CALIBRATOR (1)
ST AIA-PACK ACTH CALIBRATOR (1)
AIA-PACK PRL CALIBRATOR (1)
AIA-PACK BMG CALIBRATOR (1)
AIA-PACK IRI CALIBRATOR (1)
AIA-PACK PAP CALIBRATOR (1)
AIA-PACK HGH CALIBRATOR (1)
ST AIA-PACK CK-MB CALIBRATOR (1)
AIA-PACK C-Peptide CALIBRATOR (1)
AIA-PACK 19-9 CALIBRATOR (1)
AIA-PACK CA 125 CALIBRATOR (1)
AIA-PACK TgAb CALIBRATOR (1)
ST AIA-PACK FOLATE CALIBRATOR (1)
ST AIA-PACK LH II CALIBRATOR (1)
ST AIA-PACK Myoglobin CALIBRATOR (1)
ANNEX II: AIA-PACK SAMPLE DILUTING SOLUTION Series:
Revision: 16/05/2011

Catalogue
Description
Number
020502 AIA-PACK 27.29 SAMPLE DILUTING SOLUTION
020514 AIA-PACK RBC FOLATE SAMPLE DILUTING SOLUTION
020552 AIA-PACK AFP SAMPLE DILUTING SOLUTION
020553 AIA-PACK FER SAMPLE DILUTING SOLUTION
020554 AIA-PACK CEA SAMPLE DILUTING SOLUTION
020555 AIA-PACK PRL SAMPLE DILUTING SOLUTION
020558 AIA-PACK T4 SAMPLE DILUTING SOLUTION
020560 AIA-PACK IRI SAMPLE DILUTING SOLUTION
020561 AIA-PACK βHCG SAMPLE DILUTING SOLUTION
020562 AIA-PACK PAP SAMPLE DILUTING SOLUTION
020563 AIA-PACK PA SAMPLE DILUTING SOLUTION
020565 AIA-PACK FSH SAMPLE DILUTING SOLUTION
020566 AIA-PACK HGH SAMPLE DILUTING SOLUTION
020569 AIA-PACK CK-MB SAMPLE DILUTING SOLUTION
020574 AIA-PACK E2 SAMPLE DILUTING SOLUTION
020581 AIA-PACK PROG SAMPLE DILUTING SOLUTION
020582 AIA-PACK TT3 SAMPLE DILUTING SOLUTION
020584 AIA-PACK C-Peptide SAMPLE DILUTING SOLUTION
020571 AIA-PACK SAMPLE DILUTING SOLUTION
020587 AIA-PACK CORT SAMPLE DILUTING SOLUTION
020588 AIA-PACK &$ SAMPLE DILUTING SOLUTION

0020590 AIA PACK TPOAb/T

AIA-PACK TPOAb/TgAbAb SAMPLE DILUTING SOLUTION
020592 AIA-PACK FOLATE SAMPLE DILUTING SOLUTION
020593 AIA-PACK B12 SAMPLE DILUTING SOLUTION
020594 AIA-PACK TSH 3rd-Gen SAMPLE DILUTING SOLUTION
020595 AIA-PACK IgEII SAMPLE DILUTING SOLUTION
020596 AIA-PACK LH II SAMPLE DILUTING SOLUTION
025504 ST AIA-PACK Testosterone SAMPLE DILUTING SOLUTION
025505 ST AIA-PACK cTnI 2nd-Gen SAMPLE DILUTING SOLUTION
025512 ST AIA-PACK PSA II SAMPLE DILUTING SOLUTION
025513 ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION
025517 ST AIA-PACK Cystcin C SAMPLE DILUTING SOLUTION
025521 ST AIA-PACK ACTH SAMPLE DILUTING SOLUTION
025522 ST AIA-PACK DHEA-S SAMPLE DILUTING SOLUTION
025597 ST AIA-PACK Myoglobin SAMPLE DILUTING SOLUTION